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Regulatory & Legal Counsel (IRB Specialization)

Active
Federal

Contract Overview

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This subcontract opportunity, titled Regulatory and Legal Counsel with an IRB Specialization, seeks a provider to deliver specialized legal expertise for prime contractors working on NIH/NCATS SMART IRB projects. The primary objective is to ensure strict compliance with the Common Rule under 45 C.F.R. Part 46. Key responsibilities include updating the SMART IRB authorization agreement to align with current federal regulations and policies, as well as providing legal guidance and responses to the user community. The selected contractor will be responsible for delivering updated authorization agreements and formal legal opinion memos. This requirement is associated with the National Institutes of Health Nida under the Department of Health and Human Services, falling under NAICS code 541110. Interested parties should note the response deadline of November 13, 2026.

General Info

Legal counsel for NIH SMART IRB projects ensuring Common Rule compliance by November 2026.

NAICS

541110 - Offices of Lawyers

Place of Performance

MD, USA

Set-Aside

NONE

Documents

This scope was carved out of 75N98026Q00287.

The full solicitation package (2 documents), including the RFP, is on the prime solicitation, not on this scope.

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SMART IRB Governance, Administration, and Operations Support (GAOS)

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health Nida
ContactsNo contacts available
OfficeN/A
Office AddressN/A
ContactsNo contact information available

Full Description

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Provides legal expertise for prime contractors on NIH/NCATS SMART IRB projects. Updates the SMART IRB authorization agreement in conformance with federal regulations and policies, provides legal responses to the user community, and ensures compliance with the Common Rule (45 C.F.R. Part 46). Delivers updated authorization agreements and legal opinion/guidance memos.

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